MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARTIS PHENO; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10849000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.Internal id#: (b)(4).

Event Description

Siemens became aware of an event that occurred while operating the artis pheno system.During an interventional procedure, the user reported unintentional system movements.The c-arm pilot swivel button was stuck, and the operator had to press the button for opposite direction to stop the c-arm movement.Siemens is unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

H3, h6: siemens healthcare completed the investigation of the reported event.As previously reported, siemens became aware of an event that occurred while operating the artis pheno system.During an interventional procedure, the user reported unintentional system movements.The clockwise swivel movement of the c-arm continued even though the operator removed their finger from the movement button.The movement was stopped by pressing the button that turns the c-arm in the opposite direction (counterclockwise).The procedure was then continued and finished on that system.To resolve the problem finally, the pilot module was exchanged as part of a service activity.The detailed investigation of the exchanged part showed that the button got stuck due to a tear of the button's soft membrane.The soft membrane was stuck between the switch and the cover, causing the movement to continue even after the button is no longer pressed.This is the first case where the button got stuck that an unintended swivel c-arm movement was performed.Collision prevention mechanisms such as the collision computer and collision sensors are in place for this kind of erroneous scenarios.Also, the movement can be stopped using the emergency button.The instruction for use gives adequate instructions.In this case, the movement was stopped by pressing the button that turns the c-arm counterclockwise.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation, which leads to a corrective action of the installed base, could not be determined by the investigation.No further actions are needed for this complaint.The complaint has been closed.

• Brand Name: ARTIS PHENO
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15971441
• MDR Text Key: 308099989
• Report Number: 3004977335-2022-55079
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1